Aspen Pharmacare reacts to FDAs directive for a batch of Johnson & Johnson COVID-19 vaccines to be destroyed

SOUTH AFRICA – Aspen, a global multinational specialty pharmaceutical company, has sqaid in a statement released to the press that they are disappointed to learn specific batches of the Johnson & Johnson COVID-19 vaccine manufactured at  Gqeberha production site and designated for the South African market have to be destroyed due to the Good Manufacturing Practice risk of isolated material in the drug substance supplied to Aspen by Johnson & Johnson from their contract manufacturing partner in the USA, Emergent.  The batches manufactured had been retained in storage awaiting the…

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Philips recalls ventilators, sleep apnea machines amid pandemic due to cancer related risks

NETHERLANDS – Dutch medical equipment company Philips has recalled some breathing devices and ventilators because of a foam part that might degrade and become toxic, potentially causing cancer. Philips Chief Executive, Frans van Houten, who said the company was one of the largest makers of sleep apnea machines and ventilators, recounted that up to 4 million worth of equipment will be recalled. Foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways, the group said, as it announced the recall. Gases released by the…

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South Africa rolls back on FDA unwholesome-termed Johnson&Johnson COVID vaccines

SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has announced it will not release Johnson& Johnson(J&J) vaccines produced using the drug substance batches that were not suitable. South Africa, which is struggling to roll out its inoculation program as it enters a third wave of the pandemic, said it will pull two million of doses of the Johnson & Johnson vaccine following contamination concerns at one of the US drug maker’s sites. This follows an announcement made by the US Food and Drug Administration that millions of…

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UAE bars entry for Uganda and DR Congo travelers over Covid-19 scare

UAE – The United Arab Emirates state news agency has announced that entry for travelers coming from Uganda and DR Congo has been suspended as part of efforts to contain the spread of the coronavirus. The measure applies to transit passengers, in addition to passengers who have travelled through these countries in the last 14 days prior to their arrival in UAE. However, Emirati citizens, diplomatic passport holders and official delegations are exempt from the measures. The decision which was announced by the National Emergency Crisis and Disaster Management Authority…

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USD 3.6 million worth of illegally sold medicines and devices seized in UK as part of global crackdown

UK – Over 3 million medicines and medical devices valued at over £9 million have been seized by UK officers as part of a global operation tackling the illegal online sale of medicines and medical devices. In the UK, 113,000 illegally operating websites were also removed or had their URLs blocked. Eight search warrants were executed, with 7 criminals arrested. Under Operation Pangea, over 100 countries joined forces to seize non-compliant medical products and also to identify and remove thousands of illegally operating websites and URLs offering medicines and devices.…

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Dr Reddy’s recalls 2,980 bottles of cholesterol lowering drug in US

INDIA – Drug major Dr Reddy’s Laboratories is recalling 2,980 bottles of Atorvastatin Calcium tablets in the US due to quality issues. Atorvastatin is indicated to lower cholesterol in the blood for adults and children over ten years of age. The drug is also prescribed to lower the risk of heart attack and stroke in patients with cardiovascular diseases, diabetes, and other risk factors such as eye problems, kidney diseases, or high blood pressure. As per the US Food and Drug Administration’s latest Enforcement report, the Hyderabad-based drug major is…

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Ghana goes herbal in health products as FDA trains practitioners on safety and efficacy

GHANA – The Bono, Bono East, and Ahafo Regions Office of the Food and Drugs Authority (FDA) has intensified measures to guarantee the safety and efficiency of herbal products for public consumption. The Authority has thus embarked on regional education, sensitization, and knowledge acquisition workshop for herbal medical practitioners in the three regions. Madam Akua Amponsaa Owusu, the Director in charge of the Authority for the three regions said about 180 herbal medicine practitioners in the Bono Region would be imparted with requisite knowledge about the herbal medicine manufacturing industry…

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Moderna seeks full FDA approval for its Covid vaccine in a bid to reinforce fight against Covid-19

U.S – Moderna has applied for full approval of its Covid vaccine, a move that will see the drug maker attain rights to market the shots directly to consumers. The Moderna vaccine was granted emergency use approval by the FDA in December. The application by Moderna follows Pfizer’s application to have their vaccine granted a biologics license for use in people 16 and older in the U.S. Emergency use approval gives conditional approval based on two months of safety data whereas a biologics license application or a request for full…

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Pharmaceutical knowledge database DrugBank expands into new regions to compound global influence

CANADA – DrugBank, the world’s most complete and up-to-date pharmaceutical knowledge database, expands operations into Austria, Colombia, Indonesia, Italy, Malaysia, Thailand, and Turkey to better serve global partners. DrugBank augments human intelligence to improve the world’s health by offering a suite of products that enable healthcare companies to improve healthcare delivery through precision medicine or clinical software application, while uncovering insights by applying data science to drug discovery.  “With these new additions, our pharmaceutical knowledge base becomes even more accessible and comprehensive,” explains Mike Wilson, CEO of DrugBank.  Wilson continues…

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FDA approves targeted therapy for KRAS lung cancer mutation

U.S – The Food and Drug Administration has approved a targeted therapy drug by AMGEN INC for non-small cell lung cancer with a specific mutation in a gene known as KRAS. The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumours with the KRAS mutation in around 36 percent of patients in clinical trials. This medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13 percent of non-small cell lung cancers, or NSCLC, the most common type of lung…

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